About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

Clinicaltrials.gov identifier NCT03942757

Recruitment Status Completed

First Posted May 8, 2019

Last update posted March 23, 2020

Study Description

Brief summary:

Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

  • Condition or Disease:Preterm Infant
    Jaundice, Neonatal
    Phototherapy
  • Intervention/Treatment: Other: bilirubin serum level determination
    Other: Phototherapy
  • Phase: N/A
Detailed Description

Only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant. This study is a prospective, monocentric, observational study. Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment. The decrease in bilirubin serum level before and after phototherapy treatment will be measured. This decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant. The investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.

Study Design
  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 200 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Observation after educational program
An educational program will be implemented in the unit after this first period. 100 preterm infant will be included in a second part of this observational study.
Other: bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured

Other: Phototherapy
Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
: observation before educational program
100 preterm infant medical records will be studied in a first part of this observational study
Other: bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured

Other: Phototherapy
Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
Outcome Measures
  • Primary Outcome Measures: 1. Change in bilirubin serum level (μmol/L/h) [ Time Frame: before and 24 hours after start of phototherapy treatment ]
    Change in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)
  • Biospecimen Retention: Samples Without DNA

    serum

Eligibility Criteria
  • Ages Eligible for Study: up to 1 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria
Criteria

Inclusion Criteria:

- preterm infant less than 35 weeks gestation

- preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie

- preterm infant placed in an incubator

- preterm infant with a jaundice requiring treatment according to NICE guidelines

- preterm infant with a no hemolytic disease

- preterm infant with informed written consent from the parents

Exclusion Criteria:

- preterm infant more than 35 weeks of gestation

- preterm infant with hemolytic disease

- preterm infant with Jaundice related to a cholestasis

- Jaundice requiring exchange transfusion

Contacts and Locations
Contacts
Locations

France
CHU Amiens
Amiens

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

More Information
  • Responsible Party: Centre Hospitalier Universitaire, Amiens
  • ClinicalTrials.gov Identifier: NCT03942757 History of Changes
  • Other Study ID Numbers: PI2018_843_0021
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: March 23, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centre Hospitalier Universitaire, Amiens: preterm infant
    jaundice
    bilirubin
    phototherapy
    educational program
  • Additional relevant MeSH terms: Premature Birth
    Jaundice, Neonatal
    Jaundice